Sr Regulatory Associate PM; US or LATAM

Sr Regulatory Associate PM (US or LATAM Based Only)

Updated:
Yesterday

Location:

USA-IA-Remote

Job :

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

We bring the customer and the patient to the center of everything we do and continually simplify our work to make Syneos Health easier to work with and to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers and innovate as a team to help our customers achieve their goals.

• Under limited supervision, perform detailed and confidential project-related duties directly related to regulatory submissions and regulatory compliance.
• Perform general project administrative duties as required.
• Create and edit regulatory reports, summarize data in the public domain, conduct quality control review of documents, and collect and analyze data to produce reports to support INDs, NDAs/MAAs, drug master files, variations, renewals, marketing authorization transfers, and other lifecycle maintenance activities.
• For non-complex submissions, independently prepare and submit full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations.
• Undertake information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures.
• Conduct quality control reviews of documents and track until final submission or delivery to client.
• Attend client meetings as needed and build client relationships in support of projects and deliverables.
• Assist in training and mentoring of team members depending on project requirements.

• 3-5 years of regulatory experience within the industry.
• BS/BA degree or equivalent practical experience.
• Experience in a work-related area preferred.
• Excellent interpersonal and communication skills.
• Advanced skills in Microsoft Office Applications.
• Strong analytical skills.
• Ability to work independently and to understand and carry out detailed instructions.
• Ability to interact with staff from multiple departments.
• Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
• Fluent in speaking, writing, and reading English.
• In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards (e.g., eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS).

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us at

Salary Range: $47,000 - $79,900 USD.